Pharmaceutical Administration and Regulations in Japan - Nihs

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the safety of drugs, the reliability of the data should be assured so that the results obtained are correctly analyzed and assessed. For this purpose, all toxicity tests conducted to support applications for new drug manufacturing and marketing approval and reexamination must be conducted in accordance with the Good Laboratory Practice Standards for Safety Studies on Drugs (GLP). (Notification No. 902 of the Evaluation and Licensing Division, PFSB dated June 21, 2001 requires safety pharmacology studies be performed in accordance with the “Guidelines on Safety Pharmacology Studies” to comply with the GLP Ordinance.) Following the introduction of the GLP requirements in the US, the Japan Pharmaceutical Manufacturers Association started to prepare a draft of its voluntary GLP guidelines in 1976. In 1978, the MHW established the GLP Committee. The first GLP requirements in Japan were published in March 1982 and enforced in April 1983. They were partially revised and updated in October 1988. Thereafter, the GLP Guidelines, which had formerly been in the form of a MHLW bureau notification were legalized as the MHW Ordinance on Standards for Implementation of nonclinical Studies on Pharmaceutical Regulations in Japan: Safety of Drugs (Ordinance No.21, March 26, 1997, partially revised by Notification No. 127 of the MHLW Ordinance dated October 20, 2000) (GLP) in order to assure greater reliability than previously of the nonclinical safety data. After partial revision by Ordinance No. 114 dated June 13, 2008, this new GLP was enforced on August 15, 2008. Compared with the previous GLP, the MHW Ordinance GLP stipulates various responsibilities, including that of the sponsor when requesting outside facilities to perform nonclinical studies. The ordinance requires establishment and defines the responsibilities of Quality Assurance Units, the obligation of the management of testing facilities to prepare standard operating procedures (SOP) containing test methods and procedures, and the obligation of study directors to prepare study protocols and final reports. This ordinance consists of eight chapters and 19 articles as outlined below: Chapter 1 (Articles 1-4) Purpose of this ordinance, definition of terms, responsibilities of sponsors Chapter 2 (Article 5-8) Responsibilities of management of testing facilities, study directors and 2011-3 - 79 -
Quality Assurance Units Chapter 3 (Articles 9 and 10) Structures, facilities and equipment of testing facilities Chapter 4 (Articles 11 and 12) Standard operating procedures in testing facilities (prepared by management) and animal caretakers Chapter 5 (Articles 13 and 14) Handling of investigational products and comparators Chapter 6 (Articles 15 and 16) Study protocols (prepared by study director) and proper conduct of studies. Chapter 7 (Articles 17 and 18) Final reports (prepared by study director) and retention of study data Chapter 8 (Article 19) Requirements for conducting studies at more than two testing facilities Verification of the GLP ordinance compliance of study facilities performing nonclinical studies in compliance with the GLP ordinance (GLP-compliant studies) at the time of approval reviews is performed as a rule based on the results of paper and on-site reviews by the PMDA at the request of the MHLW and the MHLW decides on whether or not to accept the data concerned as approval Pharmaceutical Regulations in Japan: review data. GLP compliance reviews conducted by the PMDA are performed on the basis of the “System of Guidelines for Reviews Based on the Pharmaceutical GLP and Medical Device GLP” (Notification No. 23 of the PMDA date April 1, 2004; partially revised Notifications No. 530 of the PMDA dated June 29, 2004, No. 529 dated March 30, 2007, No. 0620058 dated June 20, 2008 and No. 0815008 dated August 15, 2008). GLP compliance conditions are evaluated in the following three categories by the GLP Evaluation Committee established by the PMDA based on the results of the GLP compliance review. Class A: Compliance with GLP. Class B: Some improvements possible but the effects of non-compliance on data reliability are considered tolerable; compliance with GLP if improvements are made. Class C: Noncompliance with GLP. When evaluated as Class A or B in the GLP compliance reviews, the results of the tests performed in the facility will be accepted, in principle, for use as review data for a period of 3 years or 2 years, respectively, from the day of notification of 2011-3 - 80 -
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2011.3 INFORMATION IN ENGLISH ON JA
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Table of Contents CHAPTER 1 ···
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4.1 GMP Compliance Reviews ····
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TABLE 3 DATA TO BE SUBMITTED WITH A
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eliability of application data. Fol
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3) Control of household products co
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health care information-processing
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eevaluation of gastrointestinal dru
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contribution to drug research and d
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Ministry of Health, Labour, and Wel
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Committee on Japanese Pharmacopoeia
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CHAPTER 2 Pharmaceutical Laws and R
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11) (License standards, restriction
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of approvals and licenses, approval
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2) Classification according to hand
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(3) Quasi-drug marketing business l
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manufacturer submits an MF registra
Page 35 and 36: (4) On-site surveys for accreditati
Page 37 and 38: y testing facilities for nonclinica
Page 39 and 40: Implementation of Clinical Studies
Page 41 and 42: December 21, 2005. Based on this La
Page 43 and 44: Activities Encouraging Illicit Cond
Page 45 and 46: (7) General review conference (main
Page 47 and 48: diseases, a decision must be made w
Page 49 and 50: and use of drugs for pediatric use
Page 51 and 52: codevelopment group and requirement
Page 53 and 54: January 28, 2011 entitled “Issuan
Page 55 and 56: pharmaceutical excipients, physicoc
Page 57 and 58: application review of raw materials
Page 59 and 60: half of the 1980s and there were al
Page 61 and 62: Patent right 1 Patent right 2 Calcu
Page 63 and 64: Foreign manufacturer with manufactu
Page 65 and 66: Table. 1 List of Main Controlled Su
Page 67 and 68: Table. 2 Divisions of the Pharmaceu
Page 69 and 70: acceptance of the data is condition
Page 71 and 72: p) Consultations on compliance with
Page 73 and 74: http://www.pmda.go.jp/topics/file/
Page 75 and 76: Approval of Manufacturing/Marketing
Page 77 and 78: Summary of biopharmaceutics and ass
Page 79 and 80: 1998 and partial revision by Office
Page 81 and 82: evised or established concerning ph
Page 83 and 84: are performed on the basis of the G
Page 85: Pharmaceuticals (ICH S2B) (Notifica
Page 89 and 90: y made to Notification No. 813 of t
Page 91 and 92: international harmonization of appr
Page 93 and 94: clinical exploration and developmen
Page 95 and 96: the primary objective of exploring
Page 97 and 98: dose not exceeding 1/100 of the dos
Page 99 and 100: must be analyzed precisely and obje
Page 101 and 102: (21) Structure and Content of Clini
Page 103 and 104: approved drugs and post-marketing c
Page 105 and 106: specified in the ICH guidelines (IC
Page 107 and 108: standards for the sponsoring of cli
Page 109 and 110: management of clinical trials (Arti
Page 111 and 112: PFSB dated October 1, 2008 and Offi
Page 113 and 114: trial sponsors (Article 59). Howeve
Page 115 and 116: e judged by personnel of the qualit
Page 117 and 118: standards, the Minister of Health,
Page 119 and 120: esults thereof. * Manufacturer, etc
Page 121 and 122: is clear that the items relating to
Page 123 and 124: carries out the duties set forth be
Page 125 and 126: in the two countries. These mutual
Page 127 and 128: PMSB dated February 22, 2000), Guid
Page 129 and 130: Information on approval reviews for
Page 131 and 132: Nonclinical studies Clinical studie
Page 133 and 134: (Table 3) Drug classification syste
Page 135 and 136: (Table 4) Drug classification syste
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Module 2 2.3: Quality overall summa
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Step 5* Q1A(R2) Q1B Q1C Q1D Q1E Q2
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Step 5* E1 Step 4* E2A Code E2B(M)
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1998. Furthermore, a new guideline,
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supervisor, quality assurance super
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work is required and retention of c
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prepared, reported in writing and r
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etain these reports. [5] The safety
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egard to results of clinical studie
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surveyed, analytical method and oth
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marketers’ compliance surveys by
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approval (known or unknown). g) Ser
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Information about adverse drug reac
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6.2 Periodic Safety Reports (Articl
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Reexamination is based on submissio
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Post-marketing surveillance (PMS) s
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Planning of early post-marketing su
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(MHLW) (PMDA [KIKO]) Selection of r
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and the Role of the Regulatory Auth
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which they are entered in package i
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the beginning of the Precautions wh
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1.5 Entries for Biological Products
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2.2 Pharmaceutical Interview Forms
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the basis of an order issued in cas
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the journals of the Japan Medical A
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Labeling requirements of excipients
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No PMDA safety assessment team (5 t
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CHAPTER 6 Health Insurance Programs
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coverage was changed to 80% of medi
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OF DRUGS LISTED IN THE NHI DRUG PRI
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(excluding those in the JP) in the
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0212-(6) of the Health Policy Burea
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1998 Sept. 1997 5% 2% (Long listed
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Table 9. Requirements for Applying
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Within 60 days as a rule or 90 days
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Index 1 15-Day reports (ADR) ......
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Quality Standards and Government Ce
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(MHLW) Office of New Drug III (PMDA
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Specified biological products .....
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(Chapter 4) Kazuyo MARUCHI Product
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